Vaginal biomechanics analyzer

ABSTRACT

The present invention includes a device and method for measuring skin elasticity that comprises: a probe, wherein the probe comprises one or more holes, a vacuum source, a pressure sensor, and one or more proximity sensors aligned about the one or more holes; and a processor for recording the deformation of the skin using a control unit comprising a microcontroller connected to the proximity and the pressure sensors, wherein the proximity sensor and the processor is adapted to automatically initiate a test when the sensor is positioned at a pre-determined distance from the skin, wherein a vacuum in the probe is capable of pulling skin into the one or more holes and the proximity sensor is capable of measuring an amount of skin drawn into the one or more holes to determine an elasticity of the skin.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and is a continuation-in-part ofU.S. patent application Ser. No. 13/564,682, filed Aug. 1, 2012, whichclaims priority to U.S. Provisional Application Ser. No. 61/574,290,filed Aug. 1, 2011, the entire contents of which are incorporated hereinby reference.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to the field of biomechanicalskin analyzers, and more particularly, to a novel biomechanical tissueanalyzer.

STATEMENT OF FEDERALLY FUNDED RESEARCH

None.

BACKGROUND OF THE INVENTION

Without limiting the scope of the invention, its background is describedin connection with pelvic organ prolapse.

The present invention relates to an electro mechanical device thatmeasures skin elasticity for assessing the viscoelastic properties ofthe anterior wall of the vagina. Vaginal wall tissue deterioration cancause pelvic organ prolapse (POP), a hernia of the pelvic organs to orthrough the vaginal opening. POP affects a large number of aging womenthat often necessitates surgical repair and tends to recur over time.Approximately 200,000 operations are performed yearly in the UnitedStates for POP. Although not life threatening, POP is life altering andresults in significant quality of life changes in women.

Medical researchers have studied vaginal wall properties in freshlyexcised tissue, at the time of surgery, using an Instron tensile testingmachine but this is limited by its applicability, namely patientsrequiring surgery. Currently, evaluation of the vaginal wall is limitedto physical examination and imaging modalities. There are noquantitative and practical devices that a physician can use during anoffice visit to measure the unique viscoelastic properties of the vaginato objectively determine tissue deterioration. The ability to measurethe elasticity of the inner walls of the vagina in healthy patients forstudy controls, patients in less advanced degrees of POP, patientsbefore and after surgical repair and patients on hormonal therapy willlead to a myriad of common vaginal interventions, from pelvic floortherapy to reconstructive surgery. Like the thermometer to objectivelydetermine how sick a feverish patient is, the present invention willserve as a diagnostic resource for clinicians and researchers interestedin the management of POP.

Skin elasticity measurement devices include US Patent ApplicationPublication No. US 2008/0234607 A1. In this US Patent Application, theuser applies a vacuum to a chamber that is placed over an area of theskin. When the vacuum draws the skin through an opening a video camerain an adjacent chamber captures light reflected from the skin.

U.S. Pat. No. 7,955,278 B1 creates a vacuum that draws the skin into achamber until the skin reaches the vacuum tube in the chamber. Thevacuum pressures are measured and pressure changes are used to calculateelasticity.

U.S. Pat. No. 5,278,776 describes the use of a camera that monitors themovement of dots placed on the skin. When the vacuum is applied the skinmoves into the chamber causing the dots to move. The elasticity isdetermined by the dot separation.

SUMMARY OF THE INVENTION

The present invention is a safe, easily insertable, user-friendly, andquickly sterilizable vaginal device that would allow rapid andreproducible measurements of different areas of the vagina, in theoffice setting. The present invention is simple to use and extremelyaccurate. The probe design is small enough to be inserted in the vagina,yet precisely measure the tissue deflection and recovery under mildsuction and vacuum release. The stored data for each patient can becompared to previously collected data to detect the changes in tissueelasticity. For the first time, the present invention allows for adirect in-vivo measurement of vaginal wall tissue properties.

In one embodiment, the present invention includes a device for measuringskin elasticity comprising: a probe, wherein the probe comprises one ormore holes, a vacuum source, a pressure sensor, and one or moreproximity sensors aligned about the one or more holes; and a processorfor recording the deformation of the skin using a control unitcomprising a microcontroller connected to the proximity and the pressuresensors, wherein the proximity sensor and the processor is adapted toautomatically initiate a test when the sensor is positioned at apre-determined distance from the skin, wherein a vacuum in the probe iscapable of pulling skin into the one or more holes and the proximitysensor is capable of measuring an amount of skin drawn into the one ormore holes to determine an elasticity of the skin. In one aspect, thecontrol unit further comprises a switch, an electronic control valve,and a liquid crystal display, and wherein the wand assembly is definedfurther as comprising a detachable handle and the probe. In anotheraspect, the control unit records and stores a vacuum data and aproximity sensor data. In another aspect, the proximity sensor comprisesa camera capable of detecting extend and shape of skin deflection. Inanother aspect, the probe further comprises at least one orifice thatcomprises a membrane to determine the rheological properties of a liquidon or about the skin. In another aspect, the processor calculates theskin elasticity of the inner walls of the vagina. In another aspect, theone or more proximity sensors are capable of detecting and measuring theshape of a body cavity into which the probe is inserted. In anotheraspect, the handle further comprises a circuit board, a proximitysensor, a data cable connection, and a vacuum tube connection. Inanother aspect, the proximity sensor is mounted on a circuit board inthe probe and attached to the handle. In another aspect, when the probeis attached to the handle, the proximity sensor fits under and alignswith a hole in the probe. In another aspect, the area surrounding thehole is polished. In another aspect, the proximity sensor is configuredto measure a distance the skin recoils when the vacuum is released. Inanother aspect, the device is adapted to measure biomechanicalmeasurements of normal and lesion-rich regions of the mouth (cheek,tongue, gingiva); rectum (assessment of fecal incontinence, rectaltumors, polyps); airway (trachea); or gastrointestinal tract (esophagus,stomach, duodenum, small intestine, large intestine); cardiovascular(heart, arteries or veins); or bladder (bladder wall compliance anddegree of detrusor muscle wall aging). In another aspect, the device isadapted for deployment via a catheter. In another aspect, the devicefurther comprises a memory connected to the processor and stores thedata from the proximity sensor data for immediate processing orprocessing at a later time.

Another embodiment of the present invention includes a device foranalyzing a skin elasticity comprising: a wand assembly comprising ahole, a probe, a proximity sensor, and a vacuum source, wherein theprobe and proximity sensor measure skin elasticity; an electroniccontrol unit configured to record the deformation of the skin measuredby the probe and proximity sensor, wherein the proximity sensor and theprocessor is adapted to automatically initiate a test when the sensor ispositioned at a pre-determined distance from the skin; and a standcapable of positioning and supporting the wand assembly inthree-dimensions to permit hands-free operation of the device. In oneaspect, the electronic control unit further comprises an electroniccontrol valve, a vacuum pump, a microcontroller, and a pressure sensor.In another aspect, the electronic control unit records and stores avacuum data and a proximity sensor data. In another aspect, theelectronic control unit further comprises a visual display. In anotheraspect, the wand assembly comprises the circuit board with the proximitysensor, a data cable connection, and a vacuum tube connection. Inanother aspect, the probe further comprises at least one orifice thatcomprises a membrane to determine the rheological properties of a liquidon or about the skin. In another aspect, the probe is configured to holda vacuum when the proximity sensor measures the amount of skin beingpulled through a hole in the probe. In another aspect, the areasurrounding the hole is polished. In another aspect, the device isadapted to measure biomechanical measurements of normal and lesion-richregions of the mouth (cheek, tongue, gingiva); rectum (assessment offecal incontinence, rectal tumors, polyps); airway (trachea); orgastrointestinal tract (esophagus, stomach, duodenum, small intestine,large intestine); cardiovascular (heart, arteries or veins); or bladder(bladder wall compliance and degree of detrusor muscle wall aging). Inanother aspect, the device is adapted for deployment via a catheter.

Yet another embodiment of the invention includes a method for analyzingskin elasticity comprising: obtaining a device for analyzing a skinelasticity comprising: a wand assembly having a vacuum source to measureskin elasticity, the wand assembly comprising one or more holes, whereina probe, a proximity sensor and a vacuum are aligned with the one ormore holes; an electronic control unit configured to record thedeformation of the skin measured; inserting the device for analyzing theskin elasticity into a body cavity, wherein the proximity sensor and theprocessor is adapted to automatically initiate a test when the sensor ispositioned at a pre-determined distance from the skin; measuring theskin elasticity using the wand assembly of the inserted device to obtaina skin elasticity data; recording the skin elasticity data using theinserted device; and analyzing the recorded skin elasticity data todetermine the skin elasticity. In one aspect, the skin elasticity datafurther comprises measuring and recording a skin movement, a change invacuum pressure, and an increment of time. In another aspect, theanalyzing of the data recorded by the device is used to generate avisual representation of the skin elasticity. In another aspect, thestep of measuring the skin elasticity using the wand assembly furthercomprises the steps of pulling and releasing a vacuum through theopening, and measuring the deformation between the skin and theproximity sensor with or without the vacuum over time to determine theskin elasticity. In another aspect, the probe further comprises at leastone orifice that comprises a membrane to determine the rheologicalproperties of a liquid on or about the skin. In another aspect, the skinelasticity data is further processed by at least one of: assessing adeformation of the skin under load; matching the compliance of asurgical mesh to that of the vaginal wall in order to enhance healing;or predicting the effects of remote perturbations of the pelvic organs(abdominal pressure, pelvic bending and twisting) on a vaginalconfiguration. In another aspect, the method comprises adapting thedevice to measure biomechanical measurements of normal and lesion-richregions of the mouth (cheek, tongue, gingiva); rectum (assessment offecal incontinence, rectal tumors, polyps); airway (trachea); orgastrointestinal tract (esophagus, stomach, duodenum, small intestine,large intestine);

cardiovascular (heart, arteries or veins); or bladder (bladder wallcompliance and degree of detrusor muscle wall aging).

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the features and advantages of thepresent invention, reference is now made to the detailed description ofthe invention along with the accompanying figures and in which:

FIG. 1 shows a preferred embodiment of the probe that is inserted intothe vagina.

FIG. 2 shows a preferred embodiment of the handle, which attaches to theprobe.

FIG. 3 is an illustration of the components of the present invention.

FIGS. 4A, 4B, 4C, and 4D set forth a flow chart of the control unit ofthe preferred embodiment.

FIG. 5 is a schematic of pneumatic vacuum system of the presentinvention.

FIG. 6 is a block diagram of the microcontroller and the electricalcomponents of the present invention.

FIG. 7 is a graph representing the data of a patient with prolapse.

FIG. 8 is a graph representing the data of a patient without prolapse.

FIG. 9 is a graph representing the data of the cheek of a patient'sface.

FIGS. 10A and 10B are graphs that show the results from a normal subject(FIG. 10A) and patient with vaginal prolapse (FIG. 10B).

FIGS. 11A to 11C shows three different graphs showing 3 consecutive 6second acquisitions (FIG. 11A), a 20 second acquisition (FIG. 11B), andthe result of 3 consecutive 6 second overlaid acquisitions (FIG. 11C).

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts thatcan be embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention and do not delimit the scope of theinvention.

To facilitate the understanding of this invention, a number of terms aredefined below. Terms defined herein have meanings as commonly understoodby a person of ordinary skill in the areas relevant to the presentinvention. Terms such as “a”, “an” and “the” are not intended to referto only a singular entity, but include the general class of which aspecific example may be used for illustration. The terminology herein isused to describe specific embodiments of the invention, but their usagedoes not delimit the invention, except as outlined in the claims.

The present invention relates to an apparatus that measures theelasticity of skin. Skin elasticity is measured to determine the effectsof medications, skin creams, surgery procedures and the effects ofaging. The present invention is designed to measure the skin elasticityof the inner walls of the vagina to detect changes in the integrity ofconnective tissues in the vagina. The present invention includes a smallprobe that allows a physician to easily perform elasticity measurementson patients during a regular office exam. The present invention providesthe physician with a medical device to determine, among otherconditions, if a woman is susceptible to prolapse, a condition thathappens when the bladder falls down into the vagina.

Skin elasticity is calculated from the data derived from the combinationof vacuum pressure, time, the amount of skin pulled by the vacuum, thelength of time the skin returns to the original shape, and the recoilreaction of the skin. The values are collected, calculated, and storedby the microcontroller unit or MCU and then down loaded to a computerthrough a data port or USB port. The data can be compiled by a computerprogram to display tables, plot graphs, indicate changes in the vaginalwall elasticity and assist physicians to diagnose any change ofelasticity and the probability of prolapse and other conditions relatedto vaginal disease.

The present invention is not limited to the vagina skin elasticitymeasurement. The present invention can test elasticity of any skin onany area of the body of any living animal. The present invention willalso test the elasticity of flexible materials such as rubber, vinyl,foams or other elastic materials.

FIG. 1 depicts a hollow tube that is oval. The wide part of the oval is0.75 inches while the narrow part of the oval is 0.625 inches. The probe1 is 5.5 inches in length and is the outer part of the wand assembly. Ahole 2 has a 10 millimeter diameter and is on the 0.75 inch surface ofthe probe. Hole 2 centerline is 0.75 inches from the rounded end of theprobe 1. The hole 2 allows the skin that is under test to pull down intothe hole when a vacuum is applied. As the skin is pulled in the hole,the proximity sensor of FIG. 2 makes measurements as described laterhere in. The probe 1 has a flange that allows for a vacuum seal whenconnected to the handle of FIG. 2. The probe 1 is removed from thehandle of FIG. 2 to clean and sterilize after use.

FIG. 2 shows the handle 3 with the proximity sensor 4 attached to acircuit board. The handle 3, is 2.75 inches in length and is 2.25 inchesin diameter. The probe 1 of FIG. 1 attaches to the handle 3 by thethreads 5 to securely hold the probe of FIG. 1 to the handle 3 and makea seal to prevent vacuum leaks. The proximity sensor 4 is preciselypositioned beneath the 10 millimeter hole of FIG. 1 when the handle 3and probe 1 are attached. The sensor circuit board 6 makes an electricaland data connection to the proximity sensor 4.

FIG. 3 is an illustration of the components used by the presentinvention to test skin elasticity. Vacuum canister 14 is evacuated to apredetermined value by an electrical vacuum pump 15. A vacuum line 16 isconnected to the electronic control unit 20. Electronic control unit 20has a liquid crystal display (LCD) 24, and switches 21, 22, and 23. Theswitches 21, 22, 23, and LCD 24 are used to perform menu selectionsdisplayed on the LCD screen 24 as described later in FIGS. 4A, 4B, 4C,and 4D. The data cable 19 of wand assembly 18 provides electrical anddata connection between the wand assembly 18 and the electronic controlunit 20. Data cable 19 is used to transmit serial data from theproximity sensor 4 of FIG. 2 to the microcontroller unit (MCU) 95described later in FIG. 6. Vacuum line 17 is connected to the wandassembly 18 and to the electronic control unit 20. The vacuum line 17allows a vacuum that is regulated by the control unit 20. The vacuumpump 15 and vacuum storage canister 14 are contained in the control unit20. The electronic control valves 88, 89 and 91 of FIG. 5 are located inthe control unit 20.

FIGS. 4A, 4B, 4C, and 4D illustrate operational flow diagrams of thepresent invention. The flow diagrams describe only three of a pluralityof skin elasticity tests that the present invention can perform.Referring to FIGS. 1 to 6, a microcontroller of the present invention isprogrammed to read and write the control values of the proximity sensor4 of FIG. 2, the vacuum pump 15, the liquid crystal display 24 of FIG.3, and the electronic vacuum valves 88, 89 and 91 of FIG. 5. Referringto FIG. 4A, the power is switched on at the step 25. At step 26 the onboard memory is accessed to retrieve the next patient number to bedisplayed on the LCD 24 of FIG. 3 screen. At step 27, the USB drive 63of FIG. 6, is synchronized to the MCU 95 of FIG. 6, the proximity sensor4 of FIG. 2 is initialized, the graphic display 97 of FIG. 6 isinitialize, and the vacuum pump 15 of FIG. 3 energized and beginsaspirating a vacuum in canister 14 of FIG. 3. At step 28, the physicianis given a choice to recover data from the previous test or to continuewith the current test. If the previous test was interrupted by a loss ofpower the all the data recorded up to the power outage will be recoveredand saved to the USB drive 63 of FIG. 6 drive at step 40. The probe 1 ofFIG. 1 is inserted in the body cavity at step 29. A synchronization step(Sync) begins testing the position of the probe in relation to thedistance measured to the skin at step 30. When the probe is in theproper position the LCD 24 of FIG. 3 displays the test choices at step31. The test is selected at step 32 by pressing one of the selectswitches 21, 22, or 23 of FIG. 3 that represents one of the testchoices. Pressing one of the switches 21, 22, 23 can lead to apre-selected program having a defined set of timed parameters, a fewnon-limiting examples follow. In one non-limiting example, switch 23 canselect a 20 second test at step 33. At step 34, the MCU 95 of FIG. 6,configures the system for the 20 second test. In another example, switch22 can select a single 6 second test at step 35. At step 36, the MCU 95of FIG. 6 configures the system for the single 6 second test. In anotherexample, switch 21 can select a 6 second test that is repeated 3consecutive times at step 37. At step 38, the MCU 95 of FIG. 6configures the system for the 6 second test that is repeated 3consecutive times. The skilled artisan will recognize that these aremerely illustrative examples of the length of testing, number of tests,variability on either the length or times tested, and/or the length oftime between the tests. For example, the test can be 1, 2, 3, 4, 5, 6,7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40 ormore seconds in length, which tests can have the same length, or can berandom, increasing, decreasing, or intermittent. Likewise, the test canbe conducted a single time, or 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,14, 15, 16, 17, 18, 19, or even 20 times. The length time between testscan be varied as well, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14,15, 16, 17, 18, 19, 20, 25, 30, 35, 40 or more seconds in length, whichspacing between tests can have the same length, or can be random,increasing, decreasing, or intermittent.

As discussed in greater detail in FIGS. 4B to 4D a series of steps areprogrammed for testing. The value of the vacuum pressure in storagecanister 14 of FIG. 3 is checked. The digital vacuum sensor 87 of FIG. 5outputs an analog signal proportional to the vacuum pressure. The signalis converted to a digital value in the microcontroller. If the vacuumpressure is below a predetermined value the vacuum pump 15 of FIG. 3 isenergized. When the vacuum pressure reaches the predetermined value inthe storage canister, the vacuum pump 15 of FIG. 3 is switched off. Theproximity sensor 4 of FIG. 2 is energized and begins outputtingmeasurements data for sync. When the selected test has completed, thedecision step 39 directs the physician to return to step 31 and select adifferent test or to finish the tests and save the data to the USB drive24 of FIG. 6. After saving the test data at step 40, the patient numberof step 26 is locked and saved in nonvolatile memory of the MCU 95 ofFIG. 6 which prevents another test to be performed using the samepatient number.

At step 41 of FIG. 4B, the sync measurements are checked. Sync assiststhe physician to determine an accurate probe placement before the testbegins. When 10 consecutive sync values fall within a predeterminedrange the test automatically starts at step 42. If the sync indicatesthe probe is not in position, then at step 43 the probe must berepositioned to prevent distorted measurements. At step 44, the variablesolenoid valve 89 of FIG. 5 is energized and a vacuum is created in thewand assembly 92 of FIG. 5. A small portion the inner wall of the vaginabegins to pull into the hole 2 of FIG. 1. The vacuum sensor 90 of FIG. 5begins sensing the change from atmospheric pressure to a vacuum. Thistest requires the vacuum pressure to step down from 0 to −150 mm/hg in alinear mode over 6 seconds. At step 45 the MCU 95 of FIG. 6 checks thevacuum pressure at 1/10 of a second intervals and computes the correctdigital vacuum value for each interval. If the vacuum value in aninterval is not correct the MCU 95 of FIG. 6 compensates by changing thecurrent imposed on the variable solenoid valve 89 of FIG. 5. Theaperture opening in the variable solenoid valve 89 of FIG. 5 increasesas the current increases and decreases as the current decreases whichcauses an air flow regulation in the probe. Simultaneously, at step 46the proximity sensor 4 of FIG. 2 sends measurement data to the MCU at1/10 of second intervals. At step 47 the graphic display 97 of FIG. 6begins charting a real time graph displaying the relationship of skinbeing pulled into the hole 2 of FIG. 1 vs. time. Simultaneously, thevacuum and proximity sensor values are saved in the MCU random accessedmemory (RAM) at step 48. When 60 data points are recorded by the MCU atstep 49 the solenoid valve 91 of FIG. 5 is energized causing the vacuumto go to 0 at step 50. The data points continue to be charted by thegraphic screen at step 51 and stored in RAM for an additional 14 secondsor 140 data points of proximity data. When 140 vacuum data points and140 data points of proximity data are reached at step 52 the proximityand vacuum data is stored in nonvolatile memory at step 53. Additionaltests are selected at step 54 or the physician can select a differenttests profile at step 39 of FIG. 4A. If the tests are completed, thedata can be saved to a USB drive at step 40 of FIG. 4A.

FIG. 4C describes a flow chart to perform a 6 second test. Steps 27through 31 of FIG. 4A are repeated to initially prepare the presentinvention for the test. At step 32 on FIG. 4A, the 6 second test isselected at step 35 by pressing button 22 of FIG. 3. The MCU 95 of FIG.6 configures the system for the 6 second test at step 36, by checkingthe value of the vacuum pressure in storage canister 14 of FIG. 3 withthe digital vacuum sensor 87 of FIG. 5. The sensor outputs an analogsignal proportional to the vacuum pressure. The sensor analog voltage isconverted to a digital value in the MCU. If the vacuum pressure is belowa predetermined value the vacuum pump 15 of FIG. 3 energized. When thevacuum pressure in the storage canister, reaches the predetermined valuethe vacuum pump 15 of FIG. 3 is switched off. The proximity sensor 4 ofFIG. 2 is energized and begins outputting measurement data for sync. Atstep 55, the sync measurements are checked. When 10 consecutive valuesat step 56 fall within a predetermined range the test automaticallystarts at step 57. If the sync indicates the probe is not in position,then at step 56 the probe must be repositioned to prevent distortedmeasurements. At step 58 variable solenoid vacuum valve 89 of FIG. 5 isfully opened and a vacuum is created in the wand assembly. A smallportion the inner wall of the vagina begins to pull into the hole 2 ofFIG. 1. The vacuum sensor 90 of FIG. 5 begins sensing the change fromatmospheric pressure to a vacuum. At step 60 the proximity sensor 4 ofFIG. 2 begins sending data to the MCU at 1/10^(th) of a secondintervals. At step 60 the graphic display 97 of FIG. 6 starts charting areal time graph displaying the relationship of skin being pulled intothe hole 2 of FIG. 1 vs. time. The data from the vacuum sensor 90 ofFIG. 5 and the proximity sensor 4 of FIG. 2 are stored in the RAM of theMCU at step 61. For example, in less than 1 second the predeterminedvacuum value can be reached at step 63 and the MCU switches off thevariable solenoid valve 89 of FIG. 5 and energizes solenoid valve 91 ofFIG. 5 at step 63 to release the vacuum. The graphic display continuescharting the data at step 64 until 60 proximity sensor data values and60 vacuum values (step 65) have been recorded to RAM of the MCU. Thedata are stored in nonvolatile memory in the MCU at step 66. Additionaltests are selected at step 67 or the physician can select a differenttest profile at step 39 of FIG. 4A. If the tests are completed, the datacan be saved to a USB drive at step 40 of FIG. 4A.

FIG. 4D flow chart describes the steps of the present invention toperform three consecutive 6 second tests. Each test consists of 180 datapoints of proximity sensor 4 of FIGS. 2 and 180 data points of vacuumsensor 90 of FIG. 5. Steps 27 through 31 of FIG. 4A are repeated toinitially prepare the present invention for the test. At step 32 on FIG.4A the 3 consecutive 6 second test is selected at step 37 by pressingbutton 21 of FIG. 3. The MCU 95 of FIG. 6 configures the system for thethree consecutive 6 second test at step 38 on FIG. 4A, by checking thevalue of the vacuum pressure in storage canister 14 of FIG. 3 with thedigital vacuum sensor 87 of FIG. 5. The sensor outputs an analog signalproportional to the vacuum pressure. The sensor analog voltage isconverted to a digital value in the MCU. If the vacuum pressure is belowa predetermined value the vacuum pump 15 of FIG. 3 energized. When thevacuum pressure reaches the predetermined value in the storage canister,the vacuum pump 15 of FIG. 3 is switched off. The proximity sensor 4 ofFIG. 2 is energized and begins outputting measurement data for sync. AtFIG. 4D step 69 the sync measurements are checked. When 10 consecutivevalues at step 70 fall within a predetermined range the testautomatically starts at step 72. If the sync indicates the probe is notin the correct position, then at step 71 the probe must be repositionedto prevent distorted measurements. At step 73 variable solenoid vacuumvalve 89 of FIG. 5 is fully opened and a vacuum is created in the wandassembly. A small portion the inner wall of the vagina begins to pullinto the hole 2 of FIG. 1. The vacuum sensor 90 of FIG. 5 begins sensingthe change from atmospheric pressure to a vacuum. At step 74 theproximity sensor 4 of FIG. 2 begins sending data to the MCU at 1/10^(th)of a second intervals. At step 75 the graphic display 97 of FIG. 6starts charting a real time graph displaying the relationship of skinbeing pulled into the hole 2 of FIG. 1 vs. time. The data from thevacuum sensor 90 of FIG. 5 and the proximity sensor 4 of FIG. 2 arestored in the RAM of the MCU at step 76. In less than 1 second thepredetermined vacuum value is reached at step 77 and the MCU switchesoff the variable solenoid valve 89 of FIG. 5 and energizes solenoidvalve 91 of FIG. 5 at step 78 to release the vacuum. At step 79 theproximity sensor 4 of FIG. 2 and the vacuum sensor 90 of FIG. 5 datacontinue to be stored in the RAM of the MUC and charted by the graphicdisplay. When 60 proximity sensor data values and 60 vacuum sensor datavalues have been recorded by the RAM of the MCU at step 80 the testends. The decision step 81 determines if there have been 3 consecutivetests performed. If not, then another 6 second test begins by firststarting the vacuum pump 15 of FIG. 3 and switching it off when thestorage canister 14 of FIG. 3 reaches a predetermined vacuum at step 82and then restart the test at step 72. If 3 tests have been performed,the physician has a choice at step 83 to restart another threeconsecutive 6 second test at step 69, select a different test profile atstep 39 of FIG. 4A or go to step 40 of FIG. 4A and save the data to aUSB drive. The present invention is not limited to the described threetests, as outlined hereinabove. A plurality of preprogrammed tests arepossible to determine skin elasticity, including but not-limited to:variable time per test, variable vacuum, variable measurements, variabletimes between tests, and/or variable proximity.

FIG. 5 is a schematic of the pneumatic vacuum system of the presentinvention. The vacuum pump 84 is connected by vacuum tubing to a checkvalve 85 to prevent air from flowing back into the vacuum canister 86after the vacuum pump is switched off. The vacuum canister 86 is used asa vacuum reservoir for fast evacuation of air through the vacuum system.An electronic vacuum sensor 87 is connected by tubing the vacuumcanister 86 and senses the vacuum. The vacuum sensor outputs an analogvoltage proportional to the vacuum pressure in the canister. The analogvoltage is used by the MCU 95 of FIG. 6 to determine the vacuum pressureand keep a constant vacuum pressure in the vacuum canister 86. The MCUswitches the pump on if the vacuum is lower than a predetermined vacuumvalue and off at a preset higher vacuum value. Solenoid valve 88 isconnected by tubing to electronic vacuum sensor 87 and will release thevacuum in the vacuum canister 86. If the MCU detects a predeterminedvacuum value from vacuum sensor 90, solenoid valve 88 is energized andopened to bring the vacuum system to atmospheric pressure. The outletport on the electronic variable solenoid valve 89 is connected inline bytubing to the solenoid valve 88, and vacuum canister 86. The inlet porton the electronic variable solenoid valve 89 is connected inline bytubing to the vacuum sensor 90 and the wand assembly 92. The electronicvariable solenoid valve 89 controls the vacuum pressure level that isproportional to the current applied to the solenoid valve 88 by the MCU95 of FIG. 6. Flow restriction is one of the parameters used in anelasticity test. Solenoid valve 91 is connected by tubing to the inletside of electronic variable valve 89 and when opened releases the vacuumpressure in the wand assembly 92. Vacuum sensor 90 is connected bytubing to the inlet side of electronic variable solenoid valve 89 andsends an analog voltage proportional to the vacuum pressure of the wandassembly 92 to MCU 95 of FIG. 6. The data values from the vacuum sensorare stored in the RAM of the MCU during tests and are used incalculating current levels to regulate the vacuum levels.

FIG. 6 is a block diagram that illustrates the electronic components ofthe present invention. MCU 95 is programmed to perform the tasksrequired to control all the required functions of the flow charts, FIGS.4A, 4B, 4C, and 4D. The power is preferably a 12 volt direct currentpower supply 93. The power switch 94 switches on the power to the MCU95. Vacuum solenoid valve 88 is electrically connected to an I/O portthat provides power to open the valve to release the vacuum in vacuumcanister 14 of FIG. 3. Vacuum sensor 87 is electrically connected to anA/D port on MCU 95 that reads the analog voltage output from the sensorand converts it to a digital signal used by the MCU 95 to switch on andoff the vacuum pump 15. Digital analog converter 96 is electricallyconnected to the MCU 95 and converts the digital signal from the MCU toan analog value for regulating the solenoid variable valve 89. Thesolenoid variable valve 89 is electrically connected to the digital toanalog converter 96 that varies the amount of current through thesolenoid. As the current increases through the valve's solenoid, valve89 opens wider, allowing more airflow. Solenoid valve 91 is electricallyconnected to an I/O port on MCU 95 and energizes the valve's solenoid ata programmed point to release the vacuum pressure on the wand assembly.Vacuum sensor 90 monitors the vacuum pressure on the vacuum lineconnected to the wand assembly by outputting an analog voltage to asecond A/D input of MCU 95. The A/D input converts the analog signal toa digital value proportional to the analog voltage. Proximity sensor 4is electrically connected to an I2C serial data ports on MCU 95. Datafrom proximity sensor 4 is used in the MCU 95 to measure the distancefrom the sensor 4 to the surface of the skin pulled through the hole 2in FIG. 1 by the applied vacuum. Liquid crystal display 24 is connectedto I/O ports of the MCU 95 to display the various menu options and testresults that are computed by the MCU 95. Graphic display 97 is connectedto a serial port on the MCU 95 to chart in real time the proximitysensor 4 data received by the MCU. Push buttons 21, 22, and 23 areelectrically connected to the MCU 95 and when pressed causes variousmenus and operator choices to be displayed on the liquid crystal display24 for performing the various tests. USB drive port 63 is electricallyconnected to MCU 95 to allow converted test data from the MCU 95 to betransferred to a USB drive. The data stored on the USB drive is downloaded to a computer that is programmed to compute, graph, and store theskin elasticity data for analysis.

FIG. 7 is a graph of the deformation of the skin in the anterior wall ofthe vagina of a patient with prolapse. The probe was inserted 5centimeters with the hole 2 of FIG. 1 pointing up. The test parameterswere selected by choosing a menu displayed on the LCD screen 24 of FIG.3. The test was set to a 20 second time period. The test parametersconsisted of a vacuum linearly increased from 0 to 150 millimeters ofmercury over a 6 second period while data measurements were recorded in1/10^(th) of a second intervals. At the end of 6 seconds the vacuum wasreleased. The data was continuously collected for 14 more seconds. 200data points from the proximity sensor and 200 data points from thevacuum sensor were transferred to a USB drive through the USB drive port63 of FIG. 6. The data stored on the USB drive is down loaded to acomputer for analysis. The skin deformed to 2.9 millimeters and droppedto 0.9 millimeters in 2/10th of a second. Over the last 14 seconds theskin gradually rose to 1.5 millimeters. The chart indicates that theanterior vaginal wall of the patient did not continue relaxation tocompletion, a sign of altered viscoelastic properties. This can beclearly seen in comparison with the continuing vaginal wall relaxationof a patient without prolapse (FIG. 8).

FIG. 8 is a graph of the deformation of the skin in the anterior wall ofthe vagina of a patient without prolapse. The test parameters were thesame as in FIG. 7. The vacuum was increased from 0 to 150 millimeters ofmercury over 6 seconds while data measurements of the proximity sensor 4of FIG. 2 and the vacuum measurements from the sensor 90 of FIG. 5 wererecorded every 1/10^(th) of a second. The test continued for 14 secondslonger still collecting data each 1/10^(th) of a second. The plotteddata show the elasticity of a patient's vagina without prolapse. Thepeak deformation at 150 millimeters of mercury was 2.1 millimeters witha relaxation from 0.75 millimeters that continued down to 0.25millimeters at the end of 20 seconds. The chart indicates the skindeformation and recovery are significantly different than in the case ofthe patient with a prolapsed vagina.

FIG. 9 is a chart of the skin deformation of the cheek on a patient'sface. The same parameters and procedures were followed as in FIGS. 7 and8. The data produced a very different graph that represents theversatility of the present invention. At the peak when the vacuumreached 150 millimeters of mercury the skin deformed to 0.55millimeters. The vacuum was released and the skin pulled back past zeroto −0.15 millimeters. At 14 seconds into the test the skin moved from−0.15 millimeters to 0. Then the skin began moving up until the test wascompleted at 20 seconds where the skin reached a 0.1 millimeterdeflection. The patient under the test was a male approximately 60 yearsold. The graph indicates the skin bouncing back and passing through zerocreating a concave effect on the skin surface. Tests performed ontighter skin surfaces showed a smaller skin deformation but not passingthrough zero. Another feature the graph depicts is the representation ofthe patient's heartbeat. The groupings of the spikes in the graph at 6seconds equals to 7 indicating a slightly faster rate of 1 per second.At 20 seconds the groupings of spikes 22 beats or a slightly faster ratethan 1 beat per second.

Additional modifications of the present invention included: a 4.3″diagonal graphic screen that displays the graph of the skin deformationin real time. The display is programmed to show three consecutive graphsfor comparing the results. Optionally, another feature assists theclinician before each test to accurately synch the initiation of ameasurement when the proximity sensor indicates the minimal amount offorce applied to the probe against the skin to create a vacuum sealwithout deforming the skin. When the force is in range the testautomatically begins. The force or proximity sensor feature improvedtest results and reduced the overall time for testing. Finally, a newprobe was design that changed the shape and reduced the size of theprobe shaft. The latest version of the probe was reduced to anapproximate diameter of 0.65″, which is approximately the size of afinger. The exterior of the probe can also be covered with a soft orviscoelastic material, and/or provided with one or more joints such thatthe probe can be flexed to provide a better fit for insertion into abody orifice or to reach a specific location with minimal discomfort ordamage to underlying or adjacent tissues.

FIG. 10A is a graph that shows the data obtained from the vagina of66-year old control patient, and FIG. 10B the data obtained from apatient with vaginal prolapse. Each test was performed at a 3 cm depthin the vagina. The tests start at 0 vacuum and ramps up to 150 mm/hglinearly over a 6 second time period. At the end of 6 seconds the vacuumis released but data continues to be recorded for an additional 14seconds.

FIGS. 11A to 11C shows three different graphs showing 3 consecutive 6second acquisitions (FIG. 11A), a 20 second acquisition (FIG. 11B), andthe result of 3 consecutive 6 second overlaid acquisitions (FIG. 11C).

The probe of the present invention allows for in vivo, reliable andreproducible, hand-free, quantitative measurements of the biomechanicalproperties of the human anterior vaginal wall. These properties includeelastic deformation during suction, followed by visco-elastic changesduring the return to baseline.

Another optional feature of the present invention is that if the systemfor some reason loses power or the connection is lost during recording,the data is saved on a memory connected to the processor and the datacan be retrieved at a later time. In addition, more memory can be addedto the circuit board so that all the information collected in a day canbe transferred immediately, or stored and processes all at once foranalysis, or can be processed sequentially throughout the day.

Yet another optional feature is polishing the surface of the area aroundthe hole. It has been found that this greatly improved suction when justbarely touching the skin. In one non-limiting example, the surfacesurrounding the hole is polished to the point that there are no longerany visible scratches.

The anterior vaginal wall is the location most susceptible to pelvicorgan prolapse (POP) compartment conditions because this is the areawhere increases in abdominal pressure (by coughing, straining, etc.)apply first. Generally, the top or apex of the vagina and the back wallor posterior compartment, meanwhile are more protected and thereforeless subject to prolapse.

The probe has been designed to create rapid deformations within onesecond suction time-intervals as well as longer deformations over sixseconds to reproduce straining efforts. The device can also includesurface markers, which serve to measure the anterior vaginal wall'sbiomechanical properties at different locations and the extent ofinsertion of the device; firstly, around 3 cm from the vaginal entranceor introitus, corresponding to the level of the bladder neck region;secondly, at 5 cm from the introitus, corresponding to the area of thebladder base. The probe can record several measurements at the samelocation. Each curve is composed of measurements obtained every1/10^(th) of a second.

It was found that the probe provides an accurate and reliable vaginalbiomechanics measurement device that is urgently needed to address thegrowing demands in the management of POP. POP affects a large number ofaging women, tends to recur over time and often requires surgicalrepair. The severe changes in quality of life for those afflicted demanda major improvement in the standard of care. The best tools forexamination at present are qualitative, based primarily on visualinspection and finger palpation.

But these measures are suboptimal in important ways because they are:(1) subject to operator variability; (2) do not allow quantitative timeseries histories; and thus (3) cannot provide accurate metrics.Therefore, the “intelligent finger” of the present invention is able toprovide quantitative information for tracking the intrinsic propertiesof, e.g., the human vaginal wall over time.

Role in diagnosis: The degree of vaginal wall tissue impairment cannotbe judged at present. Clinicians have learned to distinguishwell-vascularized, strong, thick tissues with deep rugae in younghealthy nulliparous women from thin tissues with effaced rugae andatrophic changes, characteristic of post-menopausal women. Presently,these are purely descriptive observations and not consistent because asPOP progresses, the vaginal tissue becomes even more lax and thinner.With aging, the coloration and degree of tissue elasticity can alsochange towards a more pale and stretchable vaginal wall, but there is nocurrent technique to measure, and thereby diagnose, such changes overtime from the same area of the vaginal wall.

Role in surgical treatments: The present invention can also be used toreduce the risks of serious complications from trans-vaginal mesh usagefor POP repair, because it can be used to test important vaginal walltissue properties. The present invention can be used to: (1) match meshbiomechanical properties to natural vaginal wall tissue properties, inorder to guide improved surgical mesh design; (2) determine suitablecandidates for mesh interposition when the vaginal wall exhibits verylax parameters; (3) follow remodeling of tissue changes over time; and(4) assess the quality of surgical healing.

Role in non-surgical treatments: Pelvic floor therapy as well as localvaginal wall therapy using hormonotherapy or laser vaginal rejuvenationtechniques will benefit from a direct measurement to assess progress invaginal wall tone and elasticity. The present invention can also be usedto determine if the proposed intervention has reached its goal.Nomograms of the vaginal wall tissue's intrinsic properties can beprovided using the present invention to determine the range of normalcywith aging changes. The present invention can be used to determine ifthe abnormal tissues have returned to a normal range as would beexpected if the intervention was successful. The present invention canbe used for long-term monitoring of the intervention's results.

Role in prevention: Existing literature suggests a strong relationshipbetween pregnancy and/or delivery mode (vaginal versus C-section), andthe occurrence of POP later on in life. Using the present invention theuser is able to measure from early on these intrinsic changes that arisewhen damage is detected in the post-partum phase. Thus, the presentinvention can be used to assess the status of the tissue to morespecifically guide one or several interventions to consolidate existingtissues found to have incurred early damage, including: (1) strainingprevention (avoiding heavy lifting, avoiding straining fromconstipation, maintaining proper body weight, tailoring sport activitiesto condition, treating coughing conditions, avoiding smoking); (2)hormonal supplementation when indicated, and (3) pelvic floorreeducation programs. The present invention can also be used fortracking the stabilization of early damage using bioabsorbable agentsfor pelvic tears, and for culturing and directly re-injecting vaginalsmooth muscle cells for vaginal wall tone improvement.

There are also populations at risk of POP, based either on race or onfamilial pre-disposition. These women's conditions have not been wellcharacterized in the past due to the lack of a quantitative andqualitative tool to measure their vaginal wall tissue properties. Thepresent invention provides a simple and non-invasive measurement devicethat can be part of the early stages of examination of young womenpost-puberty to determine their vulnerability to developing POP later onin life.

Pelvic organ prolapse affects millions of women worldwide and many willneed surgical repair of their vaginal wall hernias. The presentinvention allows for the first time a direct, rapid, simple, painless,and reproducible, office-based quantification of biomechanical vaginalwall tissue properties. These intrinsic changes will be measurable notonly over time for preemptive approaches in at-risk populations, butalso when damage is suspected post-partum or when guidance is needed forrepair procedures later on in life to restore quality of life.

The applications for use of the present invention include, but are notlimited to the following:

-   -   1. Arrays of vacuum chamber orifice-detector combinations to map        vaginal wall properties simultaneously at multiple sites.    -   2. Substitution of a micro camera for a deflection detector in        order to image the shape change of the tissue as it protrudes        from the orifice into the vacuum chamber. This enables        measurement of the biomechanical anisotropy of the wall tissue.    -   3. The parameters extracted from measurement sets such as        described in items 1 and 2 enable detailed finite element        biomechanical models of the tissue to be developed. These can be        employed for several purposes, including: assessment of organ        deformation under load; matching the compliance of a surgical        mesh to that of the vaginal wall in order to enhance healing;        prediction of the effects of remote perturbations of the pelvic        organs (abdominal pressure, pelvic bending and twisting) on the        vaginal configuration.    -   4. With interposition at the vacuum chamber orifice of a        suitably flaccid membrane, measurement of the rheological        properties of fluids entering the vaginal chamber (blood, mucus,        sperm).    -   5. Adaptation of the probe to biomechanical measurements of        normal and lesion-rich regions of the mouth (cheek, tongue,        gingiva).    -   6. Adaptation of the probe to biomechanical measurements in the        rectum (assessment of fecal incontinence, rectal tumors,        polyps).    -   7. Adaptation of the probe to biomechanical measurements in the        airway (trachea, etc.)    -   8. With interposition at the vacuum chamber orifice of a        suitably flaccid membrane, in situ measurement of the        biomechanical properties of airway mucus.    -   9. Adaptation of the probe to biomechanical measurements in the        esophagus.    -   10. With interposition at the vacuum chamber orifice of a        suitably flaccid membrane, in situ measurement of the        biomechanical properties of fluids lining the esophagus.    -   11. Adaptation of the probe to biomechanical measurements in the        bladder, including bladder wall compliance and degree of        detrusor muscle wall aging.    -   12. Adaptation of the probe for minimally invasive biomechanical        measurements of internal organs, including haptic assessment of        tumors, etc., during the course of various surgical procedures.        In this case the range of sites is limited only by the access        afforded by minimally invasive catheters and the like.

In addition it was found that the present invention has additionaladvantages, namely: the probe of the present invention is small enough(size of a finger) that it does not require a speculum for insertion.The only variable is the skin movement. For each test, the vacuumpressure is generally always the same value and the vacuum duration isalways the same as well. The infrared (IR) detector is located under theopening or aperture at the tip of the probe to directly measure themovement of the skin. The sync feature assures that the probe is placedproperly and at the same pressure against the skin in order tostandardize every test performed on the patient now and in the future.Too much pressure against the skin will stretch the skin and would skewthe results. Good measurement reproducibility is a strength of thedevice of the present invention. The graphs are instantly displayed inreal time and are a direct representation of skin movement. The presentinventors have observed that the vaginal skin moves differently as itrelaxes from the instant drop in vacuum pressure. The probe isultrasensitive and can detect skin rebounds past zero (like a rubberband) once the pressure drops. The present invention can detect theseminute variations. Furthermore, the present invention is sufficientlysimple to be able to use a simple MCU (micro control unit) processor, assuch; a complete computer is not a requirement to perform the test,which lowers the cost. The length of the device permits measurements atdifferent locations along the vaginal wall or in other body orifices.The device can also be held by a tripod to avoid manual interferencewith the measurements, thus enhancing data reproducibility. Finally, thedevice can be calibrated to ensure reliable measurements over time.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method, kit, reagent, orcomposition of the invention, and vice versa. Furthermore, compositionsof the invention can be used to achieve methods of the invention.

It will be understood that particular embodiments described herein areshown by way of illustration and not as limitations of the invention.The principal features of this invention can be employed in variousembodiments without departing from the scope of the invention. Thoseskilled in the art will recognize, or be able to ascertain using no morethan routine experimentation, numerous equivalents to the specificprocedures described herein. Such equivalents are considered to bewithin the scope of this invention and are covered by the claims.

All publications and patent applications mentioned in the specificationare indicative of the level of skill of those skilled in the art towhich this invention pertains. All publications and patent applicationsare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.” The use of the term “or” in the claims isused to mean “and/or” unless explicitly indicated to refer toalternatives only or the alternatives are mutually exclusive, althoughthe disclosure supports a definition that refers to only alternativesand “and/or.” Throughout this application, the term “about” is used toindicate that a value includes the inherent variation of error for thedevice, the method being employed to determine the value, or thevariation that exists among the study subjects.

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps. In embodiments of any of the compositions andmethods provided herein, “comprising” may be replaced with “consistingessentially of” or “consisting of”. As used herein, the phrase“consisting essentially of” requires the specified integer(s) or stepsas well as those that do not materially affect the character or functionof the claimed invention. As used herein, the term “consisting” is usedto indicate the presence of the recited integer (e.g., a feature, anelement, a characteristic, a property, a method/process step or alimitation) or group of integers (e.g., feature(s), element(s),characteristic(s), propertie(s), method/process steps or limitation(s))only.

The term “or combinations thereof” as used herein refers to allpermutations and combinations of the listed items preceding the term.For example, “A, B, C, or combinations thereof” is intended to includeat least one of: A, B, C, AB, AC, BC, or ABC, and if order is importantin a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB.Continuing with this example, expressly included are combinations thatcontain repeats of one or more item or term, such as BB, AAA, AB, BBC,AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan willunderstand that typically there is no limit on the number of items orterms in any combination, unless otherwise apparent from the context.

As used herein, words of approximation such as, without limitation,“about”, “substantial” or “substantially” refers to a condition thatwhen so modified is understood to not necessarily be absolute or perfectbut would be considered close enough to those of ordinary skill in theart to warrant designating the condition as being present. The extent towhich the description may vary will depend on how great a change can beinstituted and still have one of ordinary skilled in the art recognizethe modified feature as still having the required characteristics andcapabilities of the unmodified feature. In general, but subject to thepreceding discussion, a numerical value herein that is modified by aword of approximation such as “about” may vary from the stated value byat least ±1, 2, 3, 4, 5, 6, 7, 10, 12 or 15%.

Additionally, the section headings herein are provided for consistencywith the suggestions under 37 CFR 1.77 or otherwise to provideorganizational cues. These headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Specifically and by way of example, although the headings refer to a“Field of Invention,” such claims should not be limited by the languageunder this heading to describe the so-called technical field. Further, adescription of technology in the “Background of the Invention” sectionis not to be construed as an admission that technology is prior art toany invention(s) in this disclosure. Neither is the “Summary” to beconsidered a characterization of the invention(s) set forth in issuedclaims. Furthermore, any reference in this disclosure to “invention” inthe singular should not be used to argue that there is only a singlepoint of novelty in this disclosure. Multiple inventions may be setforth according to the limitations of the multiple claims issuing fromthis disclosure, and such claims accordingly define the invention(s),and their equivalents, that are protected thereby. In all instances, thescope of such claims shall be considered on their own merits in light ofthis disclosure, but should not be constrained by the headings set forthherein.

All of the compositions and/or methods disclosed and claimed herein canbe made and executed without undue experimentation in light of thepresent disclosure. While the compositions and methods of this inventionhave been described in terms of preferred embodiments, it will beapparent to those of skill in the art that variations may be applied tothe compositions and/or methods and in the steps or in the sequence ofsteps of the method described herein without departing from the concept,spirit and scope of the invention. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined by theappended claims.

What is claimed is:
 1. A device for measuring skin elasticitycomprising: a probe, wherein the probe comprises one or more holes, avacuum source, a vacuum release valve, a pressure sensor, and one ormore proximity sensors aligned about the one or more holes, wherein theproximity sensor is positioned to measure a deformation of skin bothinside and outside of the probe, wherein the vacuum source is capable ofincreasing a vacuum from 0 to 150 mm of Hg over 6 seconds, and thevacuum release valve opens to atmospheric pressure such that a surfaceof the skin defined as reference point zero; a processor for recordingthe deformation of the skin using a control unit comprising amicrocontroller connected to the proximity and the pressure sensors,wherein the one or more proximity sensors and the processor are adaptedto automatically initiate a test when the one or more proximity sensorsare positioned at a pre-determined distance from the skin, wherein avacuum in the probe is capable of pulling skin into the one or moreholes, and based on a release of the vacuum by the vacuum release valve,the one or more proximity sensors are capable of measuring an amount ofskin drawn into and out of the one or more holes of the probe todetermine an elasticity of the skin and the processor calculates a skinelasticity based on a recorded deformation both inside and outside thehole; and a display that plots concave and convex skin deformationacross the reference point zero during a single measurement to determineviscoelastic properties of the skin.
 2. The device of claim 1, whereinthe control unit further comprises a switch, an electronic controlvalve, and a liquid crystal display, and wherein the probe is definedfurther as comprising a detachable handle and the probe.
 3. The deviceof claim 2, wherein the handle further comprises a circuit board, theone or more proximity sensors, a data cable connection, and a vacuumtube connection.
 4. The device of claim 2, wherein the one or moreproximity sensors are mounted on a circuit board that is within theprobe and is attached to the detachable handle.
 5. The device of claim2, wherein when the probe is attached to the detachable handle, theproximity sensor fits under and aligns with a hole in the probe.
 6. Thedevice of claim 3, wherein the one or more proximity sensors areconfigured to measure a distance the skin recoils when the vacuum isreleased.
 7. The device of claim 3, wherein the device is adapted tomeasure biomechanical measurements of normal and lesion-rich regions ofthe mouth, cheek, tongue, gingiva, rectum; airway trachea,gastrointestinal tract, esophagus, stomach, duodenum, small intestine,large intestine; cardiovascular, heart, arteries or veins; or bladder.8. The device of claim 3, wherein the device is adapted for deploymentvia a catheter.
 9. The device of claim 3, wherein a memory is connectedto the processor that stores the data from the one or more proximitysensors for immediate processing or processing at a later time.
 10. Thedevice of claim 1, wherein the control unit records and stores a vacuumdata and a proximity sensor data.
 11. The device of claim 1, wherein theone or more proximity sensors comprise a camera capable of detectingextend and shape of skin deflection.
 12. The device of claim 1, whereinthe processor calculates the skin elasticity of the inner walls of thevagina.
 13. The device of claim 1, wherein the one or more proximitysensors are capable of detecting and measuring the shape of a bodycavity into which the probe is inserted.
 14. The device of claim 1,wherein the area surrounding the one or more holes is polished.
 15. Adevice for analyzing a skin elasticity comprising: a wand assemblycomprising a hole, a probe, a proximity sensor, a vacuum release valve,and a vacuum source, wherein the probe and proximity sensor measure skinelasticity, wherein the proximity sensor measures a deformation of skinboth inside and outside of the one or more holes of the probe, whereinthe vacuum is capable of increasing a vacuum from 0 to 150 mm of Hg over6 seconds, and the vacuum release valve opens to atmospheric pressuresuch that a surface of the skin deflects both inside and outside thehole at a point zero; an electronic control unit configured to recordthe deformation of the skin measured by the probe and proximity sensor,wherein the processor is adapted to automatically initiate a test whenthe sensor is positioned at a pre-determined distance from the skin, andwherein the proximity sensor is positioned to measure and record anamount of skin drawn into, and out of, the one or more holes of theprobe and the processor determines an elasticity of the skin inside andoutside of the probe upon release of the vacuum by the vacuum releasevalve, and the microprocessor calculates skin elasticity from therecorded deformation both inside and outside the hole; a stand capableof positioning and supporting the wand assembly in three-dimensions topermit hands-free operation of the device; and a display that plotsconcave and convex skin deformation across the point zero during asingle measurement to determine viscoelastic properties of the skin. 16.The device of claim 15, wherein the electronic control unit furthercomprises an electronic control valve, a vacuum pump, a microcontroller,and a pressure sensor.
 17. The device of claim 15, wherein theelectronic control unit records and stores a vacuum data and a proximitysensor data.
 18. The device of claim 15, wherein the electronic controlunit further comprises a visual display.
 19. The device of claim 15,wherein the wand assembly comprises a circuit board with the proximitysensor, a data cable connection, and a vacuum tube connection.
 20. Thedevice of claim 15, wherein the probe is configured to hold a vacuumwhen the proximity sensor measures the amount of skin being pulledthrough a hole in the probe.
 21. The device of claim 15, wherein thearea surrounding the hole is polished.
 22. The device of claim 15,wherein the device is adapted to measure biomechanical measurements ofnormal and lesion-rich regions of the mouth, cheek, tongue, gingiva; orrectum.
 23. The device of claim 15, wherein the device is adapted fordeployment via a catheter.